The present invention relates generally to devices aiding in insertion of steerable catheters and scopes. More particularly, the invention describes a handgrip positioned over the shaft of a scope, such as a colonoscope, and configured for measuring and recording of colonoscope manipulation forces, torques, and accelerations.
In many cases, it has been desirable to examine internal organs, passages, and the like of the human body for the purposes of diagnosis, biopsy, and therapeutic interventions. One method of examining the internal organs of the patient without major surgery is to insert a remote sensing device such as an endoscope into the body through a natural body orifice such as a colon or a specially prepared surgical opening.
The primary area of application of the invention is for the use with a colonoscope, but other devices can also be used with the handgrip of the invention. Therefore, the word “colonoscope” is used throughout this description to broadly include various types of direct vision and fiberoptic endoscopes, fiberscopes, arthoscopes, enteroscopes, laparoscopes, and other steerable and deflectable catheters, guide wires, cannulaes and tubes designed to be inserted into blood vessels, tight tissue openings, and curved passages.
Although useful for industrial applications, the preferred area of use for the device of the present invention is in medicine, and more particularly in colonoscopy. Colonoscopy is the preferred method to screen for colorectal cancer, a disease that afflicts over 100,000 patients each year in the U.S. Several million colonoscopies are performed each year in U.S. hospitals and ambulatory surgery centers. Colonoscopy requires a physician to inspect the colonic mucosal surface by advancing the colonoscope through a series of stationary and movable colonic loops using linear and rotational manipulations.
A common objective during the procedure is the optimal maneuvering of the inspection end (distal end) of the scope and positioning it in proximity to the area of interest. This maneuvering is performed by a trained operator who uses a combination of visual and tactile feedback to coordinate the maneuvers through the twists and turns found in the colon. The operator subjectively senses the resistance to the maneuvers by the “feel” of the instrument and anticipates the amount of force and torque necessary to advance the colonoscope shaft forward. The application of force to the colon and its anatomic attachments can be painful. Particularly undesirable is the frequent occurrence of excessive contact pressure on the internal tissue, which can result in pain and, in rare cases, in colon perforation. Sedation and analgesia is frequently required to make the procedure comfortable. Preliminary studies demonstrate that a significant variation between operators exists in the level of applied push/pull forces during the examination procedure, and that these forces can be excessive. Operator training programs are designed to reduce the variation in technique. The need therefore exists to provide a device allowing for an effective, low-cost method of defining best practices, and to implement these practices as a part of medical record keeping, training, ongoing education, and quality assurance.
Useful designs of a handgrip for a colonoscope with force and torque measurement capability are described in U.S. Pat. Nos. 6,981,945 and 8,033,991 by the same inventors incorporated herein in its entirety by reference. The disclosed handgrips are capable of measuring and presenting to the operator the axial and radial plane forces, torques, and accelerations applied by the operator during the manipulation of the colonoscope. Despite their comprehensive functional performance, these handgrips include complex power-driven mechanisms allowing engaging and disengaging from the colonoscope shaft for repositioning. As a result, they are fairly large and heavy. Operating these handgrips is not as convenient as it may be should these devices be smaller and lighter.
In addition to the excessive weight and size, the prior art devices were configured for engaging and disengaging with the colonoscope shaft by pushing a button which activated a motorized engaging mechanism. Such method of operating the device is inconvenient and requires operator training as it steps away from an intuitive motion of gripping the colonoscope by hand during a conventional procedure.
The need exists therefore for a handgrip for the colonoscope shaft that allows easy repositioning while designed as a simple and intuitive to operate, light weight and small in size.